Kornimate/medical-research-clean huggingface dataset:
evaluate the efficacy and safety of multiple roxadustat dosing regimens for the treatment of anemia in dialysis participants with chronic kidney disease

Conditions: CKD Anemia in Dialysis Participants

Summary: this is a randomized, open-label, multi-center study in dialysis chronic kidney disease (ckd) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period. there are 3 study periods: * screening period (up to 4 weeks) * treatment period (36 weeks) part 1: correction/conversion period (weeks 1-20) part 2: hemoglobin (hb) maintenance period (weeks 21-36) * follow-up period (4 weeks)

approximately 102 erythropoiesis stimulating agents (esa)-naïve participants and 204 esa-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below: * low weight-based dosing: 70 milligrams (mg) 3 times a week (tiw) for body weight \<60 kilograms (kg) or 100 mg tiw for body weight ≥60 kg * standard weight-based dosing: 100 mg tiw for body weight \<60 kg or 120 mg tiw for body weight ≥60 kg after 20 weeks of treatment, all eligible participants whose last 2 hb levels ≥105 grams (g)/liter (l) and change in hb over the most recent 4 weeks is \> - 10 g/l will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens. at the end of week 36, all participants will discontinue roxadustat and enter a 4-week follow-up period.

Eligibility criteria:
inclusion criteria: 1. ckd with end-stage renal disease (esrd) on either hemodialysis (hd) or peritoneal dialysis (pd) exclusion criteria: 1. positive for any of the following: human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or anti-hepatitis c virus antibody (anti-hcv ab). 2. myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to day 1. 3. history of malignancy, myelodysplastic syndrome, and multiple myeloma. 4. chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis \[sle\], rheumatoid arthritis, celiac disease). 5. clinically significant gastrointestinal bleeding. 6. women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.

Keywords: anemia chronic kidney disease dialysis hemoglobin end stage renal disease
feasibility study of cavity radiofrequency ablation in ex vivo mastectomy breast tissue

Conditions: Breast Cancer

Summary: the purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. the device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. this would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.


Eligibility criteria:
inclusion criteria: * female * age greater than or equal to 18 years. * receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). only non-cancerous breast tissue will be included in the study. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate. * because there is no patient contact with the device no medical contraindications are foreseen.

Keywords: breast mastectomy
deep brain stimulation effects on weight change and metabolic rate

Conditions: Obesity

Summary: this study focuses on lateral hypothalamic area (lha) deep brain stimulation (dbs) for severe obesity. in a previous pilot study, three subjects were implanted with a dbs electrode into the lha under an investigational device exemption (ide) and irb approved study at west virginia university. that study demonstrated the safety of dbs of the lha in these patients. these patients, who met the enrollment criteria of having prior placement of lha dbs in accordance with previous study protocol, were eligible for this study with a goal of determining optimal dbs settings.

the goal of this study was to investigate changes in resting metabolic rate (rmr) at different settings during stimulation of the lha with dbs and to find the optimal setting for increasing the rmr in two patients that previously were implanted. although 3 subjects had undergone placement of the dbs electrode in the pilot study, one subject was withdrawn from this study due to a lead breakage and medical instability pertaining to an unrelated abdominal infection. each subject utilized the metabolic chambers and deltatrac ii metabolic carts (sensormedics corporation, anaheim, california or datex-ohmeda, helsinki, finland) at pennington biomedical research center (pbrc), in baton rouge, louisiana to objectively measure the correlation of their metabolic rate to various novel settings on the dbs for a one week period. the schedule for the metabolic testing included: day 0 baseline overnight chamber with no stimulation. days 1-4 resting metabolic rate (rmr) will be performed hourly with variable lhs dbs settings. the settings will be changed approximately every 15 minutes after the dbs settings are changed. day 4 overnight chamber at ideal metabolic rate setting. after rmr test on day 4, the subject will have a dual-energy x-ray absorptiometry (dxa) scan performed to assess body composition. subjects were also be seen in clinic as often as every month but no less than every 3 months to assess changes in weight until the study ended.

Eligibility criteria:
inclusion criteria: * prior placement of lha dbs in accordance with previous study protocol exclusion criteria: * not a participant of the original lha dbs study * prior brain surgery, excluding the placement of lha dbs * taking medications with a recognized adverse event of weight change. * diagnosis of a neurological disorder, such as multiple sclerosis or stroke. * concurrent use of weight-loss prescription drug therapy or the use of over- the-counter weight loss preparations. * unable to participate in scheduled study visits

Keywords: obesity deep brain stimulation lha
stroke risk in the nas-nrc twin registry

Conditions: Cardiovascular Diseases; Cerebrovascular Accident; Myocardial Infarction; Coronary Disease

Summary: to investigate stroke risk using the national academy of sciences twin registry.

background: the epidemiology and common risk factors for cerebrovascular disease have been well documented by cross-sectional and longitudinal population surveys. these studies have generally involved unrelated individuals with little information on family history. despite a significant role in cardiovascular risk, few studies have investigated familial contributions to stroke risk, and its importance was unknown. recognition of the importance of hereditary influences on vascular disease of the heart has contributed, in large part, to the current emphasis on the molecular biology of vascular disease and a more balanced view that recognized both genetic and environmental influences on coronary artery disease. twin studies represented a simple and uniquely powerful tool for analyzing genetic and environmental contributions to complex human phenotypes. studies of cardiovascular risk have shown the importance of heritable factors, and it was hypothesized that similar genetic factors played a role in development of stroke. with improved understanding of stroke risk factors (both genetic and environmental), early prevention measures can begin in high risk groups as early as childhood, an approach already applied to cardiovascular disease. demonstration of a significant heritable risk for stroke should also prompt and help direct, further investigation into the molecular mechanisms of the genetic influences on stroke and may identify new approaches for stroke prevention and treatment, as it has for cardiovascular disease. design narrative: the twins have been surveyed periodically over the past two decades, most recently in 1985. information obtained included questions on vascular risk factors, myocardial disease, and stroke. an analysis was made on an estimation of heritable risk. a comparison was made between monozygotic (mz) and dizygotic (dz) twins. if genes influenced the prevalence of stroke, there should have been more mz twin pairs with stroke. measures of concordance and heritability were used to estimate the size of the genetic contribution. secondary analyses focussed on compound risk factors (e.g. hypertension and diabetes), less well documented risk factors (e.g. diet and personality), and the heritability of individual stroke risk factors. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
lenvatinib vs bevacizumab plus icis and haic in unresectable hcc

Conditions: Hepatocellular Carcinoma; Lenvatinib

Summary: previous studies had suggested hepatic arterial infusion chemotherapy (haic) combined with immune checkpoint inhibitors (icis) and anti-angiogenic drugs had promising anti-tumor activity in unresectable hepatocellular carcinoma (hcc). two kinds of anti-angiogenic drugs (tyrosine kinase inhibitors \[lenvatinib\] and anti-vegf antibody \[bevacizumab\]) were applied in first-line treatment of unresectable hcc. however, little is known about the difference of efficacy and safety between lenvatinib (lenhap) or bevacizumab (bevhap) combined with icis and haic in unresectable hcc.


Eligibility criteria:
inclusion criteria:patients aged 18 years or older, with unresectable, locally advanced, or metastatic hcc, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the american association for the study of liver disease criteria(15), who had received no previous treatment, had at least on measurable disease, as defined by response evaluation criteria in solid tumours version 1.1 (recist v1.1) criteria(16), had a baseline eastern cooperative oncology group (ecog) performance status of 0 or 1, had a child-pugh liver function score of 7 or less and had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin \<30μmol/l, albumin ≥30g/l, aspartate transaminase and alanine transaminase ≤5×upper limit of the normal, creatinine clearance rate of ≤1.5×upper limit of the normal, and left ventricular ejection ≥45%) - exclusion criteria:history of hiv, organ allograft, combined with other malignant tumors, evidence of hepatic decompensation, bleeding diathesis or event, and allergy to the investigational agents or any agent given in association with this trial and incomplete medical information. -
classical conditioning training for aphasia. a telemedicine approach.

Conditions: Aphasia

Summary: this study aimed at investigating the suitability of a classical conditioning for the treatment of anomic disorder. in this study 12 patients suffering from pure anomia in the chronic stage of the disease underwent a word repetition training with a computerized telemedicine protocol. each patient trained two word sets, one in a conditioned and the other in a non-conditioned training modality; a third non trained set served as control set.

in this study, a computer based word repetition protocol was administered at the distance to 12 pure anomic patients in the chronic stage of the disease. the to be repeated words were presented alongside the corresponding pictures. the timing of word and picture presentation was manipulated in order to investigate the suitability of classical conditioning to reteach the association between pictures and their names. data were analyzed at the group and at the single subject level with the aim of establishing the relative efficacy of the conditioned and non-conditioned word-repetition modality and the cognitive features predicting therapy success. in keeping with preliminary results obtained on a single case study, conditioning turned out to improve therapy gain at the group level. moreover, hints were found suggesting less generalization to untreated words in conditioned compared to non-conditioned training. non-word repetition skills was the only feature in the participants cognitive profile which was reliably linked to the therapy outcome.

Eligibility criteria:
inclusion criteria: * aphasic patients with word finding difficulty * must be able to repeat single words exclusion criteria: * severe cognitive impairment * impaired single word comprehension
post-contracture release radiation for dupuytren's disease

Conditions: Dupuytren's Disease; Dupuytren Contracture; Dupuytren Disease of Palm and Finger; Dupuytren Disease of Finger; Dupuytrens Contracture of Both Hands; Dupuytren's Disease of Palm of Right Hand; Dupuytren's Disease of Palm of Left Hand; Dupuytren Contracture of Right Palm; Dupuytren Contracture of Left Palm; Dupuytren's Contracture Left; Dupuytren's Contracture Right

Summary: to determine if the clinical impression of clinicians, ie that patients are improving with the current treatment pathway for dupuytren's (contracture release followed by radiation), can be substantiated with scientific evidence.

this is an observational, pilot study. participants will be treated according to a standard treatment pathway, which includes contracture release treatment modalities such as limited fasciectomy, pna and cch injection, followed by post-operative radiation. all enrolled participants will undergo radiation treatment as soon as possible following contracture release. radiotherapy will consist of 5 daily treatments of 300 cgy delivered to the palmar area followed by a 6-8 weeks break then a second 5 day course of radiation at 300 cgy, for a total of 3000 cgy in 10 total fractions. this dosing schedule is commonly used in the published literature. the data to be collected about participants, is their southampton dupuytren's score, history and clinical symptoms and photographs of their hand. this information will be obtained at baseline (pre-surgical intervention), at radiation treatment planning, approximately 6 weeks after completion of all radiation and at 1 and 2 years following completion of radiotherapy.

Eligibility criteria:
inclusion criteria: * diagnoses of dupuytren's disease * english-speaking exclusion criteria: - patients with dupuytren's disease who are not currently seeking treatment
integrating prep decision making into contraceptive counseling in family planning clinics

Conditions: Sexual Risk Behavior for HIV-infection; Reproductive Health

Summary: this study addresses the need for hiv prevention to be integrated into contraceptive counseling visits at family planning clinics.

the purpose of this study is to expand and enhance a prep decision aid to include the full array of available formulation options and then integrate its delivery into sexual and reproductive health (srh) settings during contraceptive counseling visits, where prep can be provided to all women who are interested. rooted in the health equity implementation framework, this study evaluates health equity and implementation determinants simultaneously along: 1) innovation characteristics; 2) clinical encounter; 3) recipients; and 4) context. in aim 1, patients (n=15-20), clinicians (n=10), and staff (n=10) at srh clinics across greater new haven, ct will be engaged for semi-structured interviews to expand and enhance an existing prep decision aid to include all available formulations and optimize its integration into srh clinics. qualitative interviews will inform infrastructure development to support prep delivery in srh clinics. in aim 2 (a hybrid type 2 effectiveness-implementation study), patients will be randomized (n=50) to receive either the prep decision aid or generic prep information prior to a clinician visit. in follow-up interviews immediately post-visit, and at months 3 and 6, primary outcomes are clinical efficacy (prep initiation) and implementation (using proctor definitions for feasibility, acceptability, penetration, and adoption) that are important for future planned scale-up.

Eligibility criteria:
patients (inclusion): * cis-women * aged 18 years or older * have a uterus * do not have hiv (by self-report) * not currently on prep * comfortable conversing in english or spanish * able to participate in informed consent procedures patients (exclusion): * people who cannot become pregnant (i.e., have had a hysterectomy or tubal ligation) * people who wish to become pregnant (will not qualify for contraceptive counseling) * have a scheduled visit with a member of the investigative team (to minimize risk of potential ascertainment bias) * participants of aim 1 cannot participate in aim 2. sexual and reproductive health (srh) clinicians will be included if they provide srh patient care at any of the participating sites. srh clinic staff will be included if they work at any of the participating sites and have patient-facing or non-patient-facing roles

Keywords: hiv prevention cis-women prep sexual reproductive health
clinical presentation of melioidosis in head and neck region

Conditions: Melioidosis; Head and Neck Infection

Summary: melioidosis in head and neck was observed including clinical presentation, diagnosis with titer, and result of treatment.

this research is retrospective study about five years ( jan 2011- oct 2016).

Eligibility criteria:
inclusion criteria: * patients who has the pus culture from head and neck region positive with burkholderia pseudomallei exclusion criteria: * no

Keywords: melioidosis head and neck clinical
serum phosphatemia predictive marker for aki diagnosis after cardiac surgery

Conditions: Cardiac Surgery With Cardiopulmonary Bypass; Complete Serum Phosphorus Measure; Complete Serum Creatinine Measure

Summary: cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . despite its delayed elevation, serum creatinine (cr) remains the goal standard to diagnose aki. hyperphosphatemia is well-know in case of aki because of its excretion decrease. moreover, serum phosphorus (ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. in case of aki, ph may reflect the decrease of renal function in this context. consequently, the purpose of this study is to evaluate the predictibility of ph to detect both aki induction and in a second time, renal recovery.

it is a one-year prospective diagnostic validation study included all patients \> 18 years-odl admitted in our center after cardiac surgery. aki is define according to kdigo criteria and classified in the groups of severity according to the cr elevation and the need of renal replacement therapy. serum cr and ph are measured at baseline before surgery , at icu admission, every 12 hours until icu discharge and every 24 hours until hospital discharge. to evaluate the predictability of of ph to diagnose aki, the postoperative ph percentage of maximal elevation (%eph) will be calculated. then the diagnostic performance of %eph wil be assessed by calculating the areas under the receiver operating characteristic curve (auc) to determine an optimal threshold with sensibility, specificity, positive predictive value and negative predictive value.

Eligibility criteria:
inclusion criteria: * all the patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation exclusion criteria: * chronic renal insufficiency with a glomerular filtration rate = 15ml / min / 1.73m2 * chronic renal insufficiency dialysed * history of single kidney or nephrectomy * vulnerable people according to the article l1121-6 of the public health code * protected adult or in the incapacity to give his consent according to the article l1121-8 of the public health code * the patient present formalizes his opposition for the continuation of the study * pregnant or breast-feeding women according to the article l1121-5 of the public health code

Keywords: acute kidney injury cardiac surgery cardiac surgery associated acute kidney injury renal replacement therapy renal recovery serum hyperphosphatemia
safety and efficacy of facial cleanser

Conditions: Healthy

Summary: this study is conducted to evaluate the safety and effectiveness of facial cleanser x containing combination of olive oil, virgin coconut oil, butylene glycol and hyaluronic acid on skin hydration and skin elasticity. the study duration is 5 weeks and the skin assessment will be carried out at baseline, week 3 and week 5.the main questions this study aims to answer are: 1. the effect of product on skin hydration. 2. the effect of product on skin elasticity. 3. to observe any adverse effect occurrence with the usage of the product.


Eligibility criteria:
inclusion criteria: * malaysia citizen * male and female (age 35-55 years old) exclusion criteria: * participants who have acne which require medical treatment. * participants taking isotretinoin * participants who had undergo any cosmetic procedures such as laser \& light treatment, botulinum toxin a injections and chemical peeling for the past 3 months * participants who are immunocompromised * participants with history of facial surgery

Keywords: aesthetic cosmetic